Non-randomised feasibility study of training workshops for Talking Therapies service high-intensity therapists to optimise depression and anxiety outcomes for individuals with co-morbid personality difficulties: a study protocol.

BACKGROUND: The NHS Talking Therapies for Anxiety and Depression programme ('TTad'; formerly Improving Access to Psychological Therapies 'IAPT') delivers high-intensity cognitive behavioural therapy (CBT) to over 200,000 individuals each year for common mental health problems like depression and anxiety. More than half of these individuals experience comorbid personality difficulties, who show poorer treatment outcomes. TTad therapists report feeling unskilled to work with clients with personality difficulties, and enhancing the training of TTad therapists may lead to improved treatment outcomes for individuals presenting with secondary personality difficulties alongside depression and anxiety. METHODS: This is a pre-post non-randomised mixed-method feasibility study, exploring the feasibility and acceptability of a 1-day training workshop for high-intensity (HI) CBT therapists. The workshop is focused on understanding and assessing personality difficulties and adapting HICBT treatments for anxiety and depression to accommodate client needs. The feasibility and acceptability of the workshop and the evaluation procedures will be investigated. It will be examined to what extent the workshop provision leads to improvements in therapist skills and confidence and explored to what extent the training has the potential to enhance clinical outcomes for this client group. DISCUSSION: This feasibility study will provide data on the acceptability and feasibility of delivering brief therapist training to adapt usual HICBT to optimise care for individuals with secondary personality difficulties seeking treatment in TTad services for a primary problem of depression and/or anxiety. The study will also evaluate proof of concept that such an approach has the potential to improve clinical outcomes for those with secondary personality difficulties and report any possible harms identified. The study will inform the design of a future randomised controlled trial designed to test the effectiveness and cost-effectiveness of the training. TRIAL REGISTRATION: ISRCTN81104604 . Submitted on 6th June 2022. Registration date: 3rd January 2023.

Preliminary clinical and cost effectiveness of augmented depression therapy versus cognitive behavioural therapy for the treatment of anhedonic depression (ADepT): a single-centre, open-label, parallel-group, pilot, randomised, controlled trial.

Background: Anhedonia (reduced interest/pleasure) symptoms and wellbeing deficits are core to depression and predict a poor prognosis. Current depression psychotherapies fail to target these features adequately, contributing to sub-optimal outcomes. Augmented Depression Therapy (ADepT) has been developed to target anhedonia and wellbeing. We aimed to establish clinical and economic proof of concept for ADepT and to examine feasibility of a future definitive trial comparing ADepT to Cognitive Behavioural Therapy (CBT). Methods: In this single-centre, open-label, parallel-group, pilot randomised controlled trial, adults meeting diagnostic criteria for a current major depressive episode, scoring ≥10 on the Patient Health Questionnaire (PHQ-9) and exhibiting anhedonic features (PHQ-9 item 1 ≥ 2) were recruited primarily from high intensity Improving Access to Psychological Therapy (IAPT) service waiting lists in Devon, UK. Participants were randomised to receive 20 sessions of CBT or ADepT, using a mimimisation algorithm to balance depression severity and antidepressant use between groups. Treatment was delivered in an out-patient university-based specialist mood disorder clinic. Researcher-blinded assessments were completed at intake and six, 12, and 18 months. Co-primary outcomes were depression (PHQ-9) and wellbeing (Warwick Edinburgh Mental Wellbeing Scale) at 6 months. Primary clinical proof-of-concept analyses were intention to treat. Feasibility (including safety) and health economic analyses used complete case data. This trial is registered at the ISRCTN registry, ISRCTN85278228. Findings: Between 3/29/2017 and 7/31/2018, 82 individuals were recruited (102% of target sample) and 41 individuals were allocated to each arm. A minimum adequate treatment dose was completed by 36/41 (88%) of CBT and 35/41 (85%) of ADepT participants. There were two serious adverse events in each arm (primarily suicide attempts; none of which were judged to be trial- or treatment-related), with no other evidence of harms. Intake and six-month primary outcome data was available for 37/41 (90%) CBT participants and 32/41 (78%) ADepT participants. Between-group effects favoured ADepT over CBT for depression (meanΔ = -1.35, 95% CI = -3.70, 1.00, d = 0.23) and wellbeing (meanΔ = 2.64, 95% CI = -1.71, 6.99, d = 0.27). At 18 months, the advantage of ADepT over CBT was preserved and ADepT had a >80% probability of cost-effectiveness. Interpretation: These findings provide proof of concept for ADepT and warrant continuation to definitive trial. Funding: NIHR Career Development Fellowship.

"I'm always going to be tired": a qualitative exploration of adolescents' experiences of fatigue in depression.

Adolescent depression is a prevalent and disabling condition, but current psychological treatments are only moderately effective. One way to enhance outcomes is to further our understanding of adolescent depression and improve our capacity to target the most frequently reported and problematic symptoms. A common but often neglected symptom of depression is fatigue, which is associated with considerable impairment and has the potential to interfere with adolescents' engagement in psychological therapies. Despite this, the experience of fatigue in adolescent depression and how we target it in treatment is currently poorly understood. Therefore, we aimed to explore adolescents' experiences and understandings of fatigue in depression, recruiting from clinical and community settings. Semi-structured interviews were conducted with 19 UK-based adolescents aged 14-18 years old with elevated symptoms of depression. Using reflexive thematic analysis, three themes were generated. Fatigue is a complex concept explored adolescents' understanding of fatigue as a dynamic, multifaceted symptom which had mental and physical components. Trapped in a cycle of fatigue considered the complex and reciprocal relationship between fatigue and other depressive symptoms, and the subsequent impact of limited energy on engagement with everyday activities. Finally, stigma as a barrier to help-seeking highlighted how adolescents were reluctant to seek help due to experienced stigma and the perception that fatigue was not a serious enough symptom. Findings from this study suggest that fatigue should be viewed as a psychological as well as somatic symptom of depression, with implications regarding the identification and treatment of fatigue in depression in routine clinical practice.

The glass half-full or half-empty: a within-subject comparison of solution-focused versus problem-focused client descriptions on therapist emotions and hope for treatment.

BACKGROUND: Intake assessments vary in their focus on strengths and solutions compared with problems. They provide therapists with first impressions of their clients. Research shows that first impressions may have strong and lasting effects. AIMS: To compare how solution- versus problem-focused case descriptions influence therapists' emotions and initial expectations for successfully working with a client. METHODS: Vignettes describing clients were manipulated to focus either on solutions and strengths, or on problems. In a within-subject experimental design, 33 (Sample 1) and 29 (Sample 2) trainee therapists each read four case descriptions (two solution-focused and two problem-focused vignettes; order fully counterbalanced). After each vignette, participants rated their affect and expectations for successfully working with the client. RESULTS: In both samples, solution-focused vignettes were associated with significantly higher levels of positive affect and positive expectations for treatment, and with significantly lower levels of negative affect, compared with problem-focused vignettes. Effect size differences between conditions were generally large (Cohen's d between .63 and 1.22). CONCLUSIONS: Focusing on clients' goals, their strengths, and actively highlighting better moments and areas of problem-free functioning may increase therapists' positive emotions and their hope for clients' successful treatment. A next step is to examine the degree to which these positive short-term effects are, in turn, predictive of better clinical outcomes in therapy. Future research could additionally examine whether supporting therapists to frame clients' initial assessments in solution-focused ways may be one way to contribute to workforce well-being.

'It just doesn't feel right' and other reasons why some people fear and avoid positive emotions.

The need to further our understanding of positive affect dysregulation in depression has been widely acknowledged. Two related relevant concepts in this realm, are Avoidance Of Positivity (AOP; referring to avoidance behaviour towards positivity) and Fear Of Positivity (FOP; referring to anxious or unpleasant feelings related to positivity). However, traditionally manifestations of AOP and FOP are considered in isolation, and self-report scales used to measure both concepts show considerable content overlap. Therefore, the first study aim was to examine how AOP and FOP relate to one another, depressive symptomatology and anhedonia, through new clearly delineated scales. For exploratory purposes, general and state-specific versions were developed. The second aim was to uncover beliefs that underlie the tendency towards AOP/FOP. An adult community sample (n = 197) completed online measures of AOP, FOP, depressive symptoms and anhedonia, and answered open-ended questions about reasons for AOP and FOP. Cross-sectionally, preliminary evidence was found for AOP and FOP being positively associated with one another, depressive symptomatology and anhedonia. Even after controlling for depressive symptomatology, anhedonia remained positively associated with AOP and FOP. So, AOP and FOP may be viable candidate mechanisms maintaining anhedonia that are worth further investigation and may be appropriate to target during treatment. Answers to the open-ended questions (n = 77) reflected various beliefs underlying AOP/FOP, which were broader than simply anticipating negative consequences of feeling positive and also touched on themes of unworthiness and social inappropriateness of feeling positive. Some theoretical and clinical implications of different beliefs underlying AOP/FOP are discussed.

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol.

BACKGROUND: Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive. METHODS: In a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D. DISCUSSION: This trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.

Nonpharmacological interventions for treating fatigue in adolescents: A systematic review and narrative synthesis of randomised controlled trials.

OBJECTIVE: Fatigue is common in adolescence and can be highly disabling if experienced persistently, with adverse psychosocial outcomes. There is a need to better understand what nonpharmacological treatments are available for adolescents suffering with persistent fatigue. The current review systematically identified, synthesised, and evaluated the evidence regarding nonpharmacological interventions for fatigue in adolescents, focusing on evaluating effectiveness, describing intervention components, and mapping interventions onto the behaviour change technique taxonomy (BCTT). METHODS: CENTRAL, EMBASE, PsycINFO, PubMed, and Web of Science were systematically searched for articles including (1) adolescents aged 10-19 years old, (2) fatigue as a primary or secondary outcome, (3) nonpharmacological interventions, and (4) randomised controlled trials. Study screening, data extraction, quality assessment, and BCTT mapping were performed independently by two reviewers. Findings were presented as a narrative synthesis, with interventions ranked by promise. RESULTS: 5626 papers were identified and double-screened, resulting in the inclusion of 21 articles reporting 16 trials. Five interventions were classified as likely promising. Interventions often involved psychoeducation, cognitive behavioural therapy, and/or physical activity, incorporating various BCTT domains, most commonly shaping knowledge, repetition and substitution, and goals and planning. However, there did not seem to be any observable differences between fatigue-targeted and non-fatigue-targeted interventions. Overall study quality was mixed, particularly in relation to power and outcome measures. CONCLUSION: There are several promising nonpharmacological interventions for adolescent fatigue, although further work is needed to determine effectiveness. Future trials need to ensure design rigour, focusing on adequate powering, validated outcome measures, and adhering to best practice reporting guidelines.

How well do Cognitive Behavioural Therapy and Behavioural Activation for depression repair anhedonia? A secondary analysis of the COBRA randomized controlled trial.

A secondary analysis of the COBRA randomized controlled trial was conducted to examine how well Cognitive Behavioural Therapy (CBT) and Behavioural Activation (BA) repair anhedonia. Patients with current major depressive disorder (N = 440) were randomized to receive BA or CBT, and anhedonia and depression outcomes were measured after acute treatment (six months) and at two further follow up intervals (12 and 18 months). Anhedonia was assessed using the Snaith Hamilton Pleasure Scale (SHAPS; a measure of consummatory pleasure). Both CBT and BA led to significant improvements in anhedonia during acute treatment, with no significant difference between treatments. Participants remained above healthy population averages of anhedonia at six months, and there was no further significant improvement in anhedonia at 12-month or 18-month follow up. Greater baseline anhedonia severity predicted reduced repair of depression symptoms and fewer depression-free days across the follow-up period in both the BA and CBT arms. The extent of anhedonia repair was less marked than the extent of depression repair across both treatment arms. These findings demonstrate that CBT and BA are similarly and only partially effective in treating anhedonia. Therefore, both therapies should be further refined or novel treatments should be developed in order better to treat anhedonia.

Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series.

Behavioural Activation (BA) is associated with a substantial evidence base for treatment of acute unipolar depression, and has promise as an easily disseminable psychological intervention for bipolar depression. Using a randomised multiple baseline case series design we examined the feasibility and acceptability of an adapted version of BA in a U.K. outpatient sample of 12 adults with acute bipolar depression. Participants were allocated at random to a 3-8 week wait period before being offered up to 20 sessions of BA. They completed outcome measures at intake, pre- and post-treatment and weekly symptom measures across the study period. Retention in therapy was high (11/12 participants completed the target minimum number of sessions), and all participants returning acceptability measures reported high levels of satisfaction with the intervention. No therapy-related serious adverse events were reported, nor were there exacerbations in manic symptoms that were judged to be a result of the intervention. The pattern of change on outcome measures is consistent with the potential for clinical benefit; six of the nine participants with a stable baseline showed clinically significant improvement on the primary outcome measure. The findings suggest adapted BA for bipolar depression is a feasible and acceptable approach that merits further investigation.

Addressing anhedonia to increase depression treatment engagement.

Anhedonia, or reward system dysfunction, is associated with poorer treatment outcomes among depressed individuals. The role of anhedonia in treatment engagement, however, has not yet been explored. We review research on components of reward functioning impaired in depression, including effort valuation, reward anticipation, initial responsiveness, reward learning, reward probability, and reward delay, highlighting potential barriers to treatment engagement associated with these components. We then propose interventions to improve treatment initiation and continuation by addressing deficits in each component of reward functioning, focusing on modifications of existing evidence-based interventions to meet the needs of individuals with heightened anhedonia. We describe potential settings for these interventions and times at which they can be delivered during the process of referring individuals to mental health treatment, conducting intakes or assessments, and providing treatment. Additionally, we note the advantages of using screening processes already in place in primary care, workplace, school, and online settings to identify individuals with heightened anhedonia who may benefit from these interventions. We conclude with suggestions for future research on the impact of anhedonia on treatment engagement and the efficacy of interventions to address it. PRACTITIONER POINTS: Many depressed individuals who might benefit from treatment do not initiate it or discontinue early. One barrier to treatment engagement may be anhedonia, a core symptom of depression characterized by loss of interest or pleasure in usual activities. We describe brief interventions to improve treatment engagement in individuals with anhedonia that can be implemented during the referral process or early in treatment. We argue that interventions aiming to improve treatment engagement in depressed individuals that target anhedonia may be particularly effective.

Examining the relationship between anhedonia symptoms and trait positive appraisal style in adolescents: A longitudinal survey study.

INTRODUCTION: Anhedonia, defined as a loss of interest and pleasure in previously enjoyable activities, is a core symptom of depression that predicts a poor treatment response in adolescents. We know little about the cognitive vulnerability factors that contribute to the development of anhedonia in youth. This cross-sectional and longitudinal survey study investigated the link between anhedonia symptoms and cognitive appraisal of positive affect. METHODS: Baseline data were collected from 392 secondary school students in the UK (aged 13-16, 54 % Female), 170 of whom went on to complete the three-month follow-up assessment (a 43 % response rate). Participants rated their anhedonia symptoms and appraisal styles which were measured in terms of use of amplifying appraisals, dampening appraisals, and fear of positive emotion. RESULTS: At baseline, greater anhedonia was significantly associated with increased levels of dampening and reduced levels of amplifying but was not significantly related to fear of positive emotion. Prospectively, greater baseline levels of amplifying uniquely predicted lower anhedonia severity at three-month follow-up, and vice-versa. There was no evidence for reciprocal prospective associations between anhedonia and, appraisal styles of dampening and fear of positive emotion. CONCLUSION: These results indicate that cognitive appraisal of positive affect is associated with concurrent and to some extent can predict future symptoms of anhedonia in youth.

A feasibility randomised controlled trial of a brief early intervention for adolescent depression that targets emotional mental images and memory specificity (IMAGINE).

Brief, evidence-based interventions for adolescent depression are urgently required, particularly for school-settings. Cognitive mechanisms research suggests dysfunctional mental imagery and overgeneral memory could be promising targets to improve mood. This feasibility randomised controlled trial with parallel symptomatic groups (n = 56) compared a novel imagery-based cognitive behavioural intervention (ICBI) to non-directive supportive therapy (NDST) in school settings. Blind assessments (of clinical symptoms and cognitive mechanisms) took place pre-intervention, post-intervention and follow-up three months later. The trial aimed to evaluate the feasibility and acceptability of the methodology and interventions, and estimate the likely range of effects of the intervention on self-reported depression. The pre-defined criteria for proceeding to a definitive RCT were met: full recruitment occurred within eleven months; retention was 89%; ICBI acceptability was above satisfactory; and no harm was indicated. Intention-to-treat analysis found large effects in favour of ICBI (relative to NDST) at post-intervention in reducing depressive symptoms (d = -1.34, 95% CI [-1.87, -0.80]) and improving memory specificity (d = 0.79 [0.35, 1.23]), a key cognitive target. The findings suggest that ICBI may not only improve mood but also strengthen abilities associated with imagining and planning the future, critical skills at this life stage. A fully powered evaluation of ICBI is warranted. Trial Registration: https://www.isrctn.com/; ISRCTN85369879.

Personality difficulties and response to community-based psychological treatment for anxiety and depression.

BACKGROUND: Previous research suggests that comorbid personality disorder may be associated with a less favourable treatment outcome for individuals with depression and anxiety disorder. However, little is known about whether personality difficulties are associated with treatment outcomes within Improving Access to Psychological Therapies (IAPT) services-the largest platform for treating depression and anxiety in England, UK. Secondary aims were to investigate i) whether individual personality difficulties are associated with treatment outcome and ii) whether findings are moderated by treatment type. METHODS: The sample included 3,689 adults who accessed community-based psychological treatment (cognitive behavioural therapy, emotional skills training, or other psychological therapy) for depression and/or anxiety disorder. Associations between personality difficulties (assessed with the Standardised Assessment of Personality-Abbreviated Scale (SAPAS)) and treatment outcomes (recovery and reliable improvement in depression/anxiety symptom scores, assessed using questionnaire-based measures) were investigated using logistic/linear regression. RESULTS: Personality difficulties were associated with a reduced likelihood of recovery (adjusted OR per unit increase on SAPAS: depression=0.87, 95%CI 0.84, 0.91; anxiety=0.86, 95%CI 0.82, 0.90) and reliable improvement (adjusted OR per unit increase on SAPAS: depression=0.88, 95%CI 0.84, 0.92; anxiety=0.85, 95%CI 0.82, 0.89). Those with three or more difficulties were over 30% less likely to recover/reliably improve. LIMITATIONS: Personality difficulties data were collected via self-report and were not available for all participants. CONCLUSION: Patients with personality difficulties have a less favourable response to psychological treatment for depression/anxiety disorder. If replicated, the findings highlight a major challenge to the way community-based psychological therapy services in England (IAPT services) are presently constituted.

Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial.

Two core features of depression include depressed mood (heightened distress) and anhedonia (reduced pleasure). Despite their centrality to depression, studies have not examined their contribution to treatment outcomes in a randomized clinical trial providing mainstream treatments like antidepressant medications (ADM) and cognitive therapy (CT). We used baseline distress and anhedonia derived from a factor analysis of the Mood and Anxiety Symptom Questionnaire to predict remission and recovery in 433 individuals with recurrent/chronic major depressive disorder. Patients were provided with only ADM or both ADM and CT. Overall, higher baseline distress and anhedonia predicted longer times to remission within one year and recovery within three years. When controlling for treatment condition, distress improved prediction of outcomes over and above anhedonia, while anhedonia did not improve prediction of outcomes over and above distress. Interactions with treatment condition demonstrated that individuals with higher distress and anhedonia benefited from receiving CT in addition to ADM, whereas there was no added benefit of CT for individuals with lower distress and anhedonia. Assessing distress and anhedonia prior to treatment may help select patients who will benefit most from CT in addition to ADM. For the treatments and outcome measures tested, utilizing distress to guide treatment planning may yield the greatest benefit. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00057577.

Short-term affective consequences of specificity of rumination about unresolved personal goals.

BACKGROUND AND OBJECTIVES: Rumination is a form of repetitive thinking that has been associated with both helpful and unhelpful consequences for mood and self-regulation. It has been suggested that the specificity of ruminative thought content may be one factor that determines whether state rumination about personal goals is adaptive. The present study tested the hypothesis that state rumination about unresolved personal goals is associated with unhelpful affective consequences only when rumination is low in specificity. METHODS: We measured the extent and specificity of uninstructed rumination following the cueing of resolved and unresolved personal goals using a 30-min go/no-go task with thought probes. Changes in state positive and negative affect from before to after cueing goals, and before to after rumination during the go/no-go task were assessed. RESULTS: Cueing unresolved goals resulted in a significant increase in negative affect, and subsequent affective recovery during the go/no-go task. Cueing unresolved goals resulted in more goal-focused rumination than cueing resolved goals. When ruminative thoughts were low in specificity, rumination mediated the association between goal discrepancies and negative affect: greater rumination about unresolved goals significantly impaired affective recovery and perpetuated negative affect. LIMITATIONS: The findings await replication in clinical populations, where rumination is more commonly associated with unhelpful outcomes. CONCLUSIONS: Greater levels of goal-focused rumination were associated with unhelpful affective consequences only when rumination was low in specificity. Specificity of thought content may be an important determinant of whether goal-focused rumination has helpful or unhelpful effects.

Making the worst of a good job: Induced dampening appraisals blunt happiness and increase sadness in adolescents during pleasant memory recall.

Previous work has shown that dampening appraisals (e.g., thinking "this is too good to last") reduce happiness and enhance sadness when adults recall positive events. In contrast, amplifying appraisals (e.g., thinking "this is the sign of good things to come") do not significantly alter affective experience during the same task. The present study examined whether this pattern holds in adolescence. Eighty-nine adolescents completed an uninstructed positive recall task before being randomized to either dampening, uninstructed control or amplifying instructions during a second positive recall task. Participants experienced a significantly smaller increase in happiness and a significantly less marked reduction in sadness when recalling a positive memory under dampening instructions, relative to both the amplifying and no instruction control conditions. There was no significant difference between the amplifying and control conditions. This broadly replicates adult findings, but the detrimental effects of dampening were less marked in adolescents than adults. Nevertheless, given that elevated dampening appraisals are associated with depressed mood, dampening may partly account for why depressed adolescents struggle to experience positive emotions, and represent a promising target for clinical intervention.

Bringing light into darkness: A multiple baseline mixed methods case series evaluation of Augmented Depression Therapy (ADepT).

Two core features of depression are elevations in negative valence system (NVS) functioning and reductions in positive valence system (PVS) functioning. Existing psychological treatments have focused on the NVS and neglected the PVS, which may contribute to sub-optimal outcomes. The present mixed methods multiple randomised baseline case series preliminarily evaluates Augmented Depression Therapy (ADepT), a novel depression treatment targeting PVS and NVS disturbance, that aims both to reduce depression and enhance wellbeing. Eleven clinically depressed participants were recruited. Intensive time series analyses showed that 7/11 participants improved on both wellbeing and depression. Reliable and clinically significant improvement was observed for 9/11 participants on at least one of these outcomes (and also across a range of other PVS and NVS outcomes). Group level analyses showed significant pre to post change on all outcomes. Benchmarking analyses indicated these effect sizes were at least comparable (and for some PVS outcomes superior) to existing treatments. Gains were largely sustained over one-year follow-up. Qualitative interviews indicated ADepT was feasible and acceptable. These findings provide preliminary support for ADepT as a novel depression treatment. Further evaluation, directly comparing ADepT to existing treatments using randomised controlled trial designs, is now required.

A commentary on research rigour in clinical psychological science: How to avoid throwing out the innovation baby with the research credibility bath water in the depression field.

Proponents of the research credibility movement make a number of recommendations to enhance research rigour in psychology. These represent positive advances and can enhance replicability in clinical psychological science. This article evaluates whether there are any risks associated with this movement. We argue that there is the potential for research credibility principles to stifle innovation and exacerbate type II error, but only if they are applied too rigidly and beyond their intended scope by funders, journals and scientists. We outline ways to mitigate these risks. Further, we discuss how research credibility issues need to be situated within broader concerns about research waste. A failure to optimise the process by which basic science findings are used to inform the development of novel treatments (the first translational gap) and effective treatments are then implemented in real-world settings (the second translational gap) are also significant sources of research waste in depression. We make some suggestions about how to better cross these translational gaps.

Evaluating Augmented Depression Therapy (ADepT): study protocol for a pilot randomised controlled trial.

BACKGROUND: While existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing. METHODS: We aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT. DISCUSSION: We will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample. TRIAL REGISTRATION: ISCRTN85278228, registered 27/03/2017.

Interoception and respiratory sinus arrhythmia in gambling disorder.

Gambling has longstanding links with excitement and physiological arousal, but prior research has not considered (a) gamblers' ability to detect internal physiological signals, or (b) markers of parasympathetic functioning. The present study measured interoception in individuals with gambling disorder, using self-report measures and a heartbeat counting task administered at rest. Resting state respiratory sinus arrhythmia (RSA), an index of heart rate variability, was measured as a proxy for parasympathetic control and emotional regulation capacity. In a case-control design, 50 individuals with gambling disorder were compared against 35 controls without gambling problems. Participants completed two self-report measures of bodily awareness and a behavioral test of heartbeat counting. A resting state electrocardiogram (5 min) was used to calculate RSA. There were no significant differences on the self-report or behavioral interoception probes. The group with gambling disorder displayed significantly reduced RSA, which at face value is consistent with reduced parasympathetic control. However, the group difference in RSA did not survive controlling for age and smoking status, as established predictors of heart rate variability. Our findings do not support any changes in interoceptive processing in people with gambling disorder, at least under resting conditions. Our observation that group differences in RSA are partly explained by smoking behavior highlights the importance of controlling for nicotine use in future research characterizing physiological functioning and emotional regulation in disordered gambling.